Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission

Executive Order 12975 of October 3, 1995

Protection of Human Research Subjects and
Creation of
National Bioethics Advisory Commission

By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:

Section 1.  Review of Policies and Procedures. (a) Each
executive branch department and agency that conducts,
supports, or regulates research involving human
subjects shall promptly review the protections of the
rights and welfare of human research subjects that are
afforded by the department's or agency's existing
policies and procedures. In conducting this review,
departments and agencies shall take account of the
recommendations contained in the report of the Advisory
Committee on Human Radiation Experiments.

(b) Within 120 days of the date of this order, each
department and agency that conducts, supports, or
regulates research involving human subjects shall
report the results of the review required by paragraph
(a) of this section to the National Bioethics Advisory
Commission, created pursuant to this order. The report
shall include an identification of measures that the
department or agency plans or proposes to implement to
enhance human subject protections. As set forth in
section 5 of this order, the National Bioethics
Advisory Commission shall pursue, as its first
priority, protection of the rights and welfare of human
research subjects.

(c) For purposes of this order, the terms “research”
and “human subject” shall have the meaning set forth
in the 1991 Federal Policy for the Protection of Human
Subjects.

Sec. 2. Research Ethics. Each executive branch
department and agency that conducts, supports, or
regulates research involving human subjects shall, to
the extent practicable and appropriate, develop
professional and public educational programs to enhance
activities related to human subjects protection,
provide forums for addressing ongoing and emerging
issues in human subjects research, and familiarize
professionals engaged in nonfederally-funded research
with the ethical considerations associated with
conducting research involving human subjects. Where
appropriate, such professional and educational programs
should be organized and conducted with the
participation of medical schools, universities,
scientific societies, voluntary health organizations,
or other interested parties.

Sec. 3. Establishment of National Bioethics Advisory
Commission. (a) There is hereby established a National
Bioethics Advisory Commission (“NBAC”). NBAC shall be
composed of not more than 15 members to be appointed by
the President. NBAC shall be subject to the Federal
Advisory Committee Act, as amended (5 U.S.C. App.).

(b) The President shall designate a Chairperson from
among the members of NBAC.

Sec. 4. Functions. (a) NBAC shall provide advice and
make recommendations to the National Science and
Technology Council and to other appropriate government
entities regarding the following matters:

    (1) the appropriateness of departmental, agency, or
other governmental programs, policies, assignments,
missions, guidelines, and regulations as they relate to
bioethical issues arising from research on human
biology and behavior; and

    (2) applications, including the clinical
applications, of that research.

(b) NBAC shall identify broad principles to govern the
ethical conduct of research, citing specific projects
only as illustrations for such principles.

(c) NBAC shall not be responsible for the review and
approval of specific projects.

(d) In addition to responding to requests for advice
and recommendations from the National Science and
Technology Council, NBAC also may accept suggestions of
issues for consideration from both the Congress and the
public. NBAC also may identify other bioethical issues
for the purpose of providing advice and
recommendations, subject to the approval of the
National Science and Technology Council.

Sec. 5. Priorities. (a) As a first priority, NBAC shall
direct its attention to consideration of: protection of
the rights and welfare of human research subjects; and
issues in the management and use of genetic
information, including but not limited to, human gene
patenting.

(b) NBAC shall consider four criteria in establishing
the other priorities for its activities:

    (1) the public health or public policy urgency of
the bioethical issue;
    (2) the relation of the bioethical issue to the
goals for Federal investment in science and technology;
    (3) the absence of another entity able to
deliberate appropriately on the bioethical issue; and
    (4) the extent of interest in the issue within the
Federal Government.

Sec. 6. Administration. (a) The heads of executive
departments and agencies shall, to the extent permitted
by law, provide NBAC with such information as it may
require for purposes of carrying out its functions.

(b) NBAC may conduct inquiries, hold hearings, and
establish subcommittees, as necessary. The Assistant to
the President for Science and Technology and the
Secretary of Health and Human Services shall be
notified upon establishment of each subcommittee, and
shall be provided information on the name, membership
(including chair), function, estimated duration, and
estimated frequency of meetings of the subcommittee.

(c) NBAC is authorized to conduct analyses and develop
reports or other materials. In order to augment the
expertise present on NBAC, the Secretary of Health and
Human Services may contract for the services of
nongovernmental consultants who may conduct analyses,
prepare reports and background papers, or prepare other
materials for consideration by NBAC, as appropriate.

(d) Members of NBAC shall be compensated in accordance
with Federal law. Members of NBAC may be allowed travel
expenses, including per diem in lieu of subsistence, to
the extent permitted by law for persons serving
intermittently in the government service (5 U.S.C.
5701-5707).

(e) To the extent permitted by law, and subject to the
availability of appropriations, the Department of
Health and Human Services shall provide NBAC with such
funds as may be necessary for the performance of its
functions. The Secretary of Health and Human Services
shall provide management and support services to NBAC.

Sec. 7. General Provisions. (a) Notwithstanding the
provisions of any other Executive order, the functions
of the President under the Federal Advisory Committee
Act that are applicable to NBAC, except that of
reporting annually to the Congress, shall be performed
by the Secretary of Health and Human Services, in
accordance with the guidelines and procedures
established by the Administrator of General Services.

(b) NBAC shall terminate two years from the date of
this order unless extended prior to that date.

(c) This order is intended only to improve the internal
management of the executive branch and it is not
intended to create any right, benefit, trust, or
responsibility, substantive or procedural, enforceable
at law or equity by a party against the United States,
its agencies, its officers, or any person.

    (Presidential Sig.)

THE WHITE HOUSE,

    October 3, 1995.